Primary Care, Communication, and Improving Children's Health
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|ClinicalTrials.gov Identifier: NCT02277899|
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment|
|Childhood Obesity Overweight Communication Weight Loss||Other: Communication regarding overweight status Other: Risk-factor assessment and counseling Other: Lifestyle behavior assessment and counseling Other: Interval follow-up to readdress weight Other: Patient-centered communication|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Primary Care, Communication, and Improving Children's Health|
|Actual Study Start Date :||October 14, 2014|
|Actual Primary Completion Date :||August 5, 2016|
|Actual Study Completion Date :||August 10, 2017|
Overweight school-age children
Overweight 6-12 year-old children. Weight status will be measured and parents complete surveys at baseline and one year later. Pediatricians will complete surveys at baseline, and after index visit. Visits will be directly video-recorded.
The impact of pediatrician clinical practices and communication strategies on child's weight status will be evaluated at one year. Clinical practices (such as risk-factor screening) that occur during the 1-year interval between well-child visits also will be assessed. Specific clinical practice elements and communication strategies that will be examined include:
Other: Communication regarding overweight status
Pediatrician-patient/parent communication regarding child's high weight status
Other: Risk-factor assessment and counseling
Counseling regarding cardiovascular risk factor assessments/results.
Other: Lifestyle behavior assessment and counseling
Counseling regarding diet and lifestyle changes to improve weight status.
Other: Interval follow-up to readdress weight
Interval follow-up to readdress weight, prior to the next well-child visit one year later. Follow-up could include ongoing care through nutrition and/or an intensive weight-management program.
Other: Patient-centered communication
Patient-centered communication will be scored as the ratio of patient to doctor-centered communication regarding weight topics. Means will be calculated for total and weight-communication-specific pediatrician, child, and parent-talk time, and patient, doctor, and the ratio of patient/doctor-centered communication scores. For the primary hypothesis, biomedical information-giving (for example, risk-factor communication) will be treated as patient-centered because the principal investigator's focus groups suggest that parents want this information, and prior research suggests that including biomedical-information giving improves the correlation of Roter's patient-centeredness measure with patient health status and satisfaction scores.
- Percent overweight [ Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later ]The percent over the median BMI percentile for age and gender. This measure changes comparably for similar weight changes in overweight and severely-obese children. In contrast, an overweight child would have to lose substantially less weight than a severely-obese child for the same change in BMI z-score.
- BMI z-score [ Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later ]Change in BMI z-score of 0.25-0.5 has been associated with reductions in cardiovascular-disease risk factors. Using both percent overweight and BMI z-score measures will allow examination of the relationship between relative weight changes and cardiovascular-disease risk-factor improvement.
- Change in the number of "5-2-1-0" behaviors [ Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later ]The "5-2-1-0" behaviors are: eat five fruits and vegetables, watch "screens" (TV, computer, tablets, video games, cell phones, etc…) two hours per day or less, be physically active for one hour per day or more, and drink zero calorie-containing beverages per day.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277899
|United States, Texas|
|University of Texas Southwestern and Children's Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Christy B Turer, MD, MHS||University of Texas Southwestern and Children's Medical Center Dallas|